Trial Outcomes & Findings for CeraVe Diabetes Mellitus (NCT NCT04724967)
NCT ID: NCT04724967
Last Updated: 2022-09-22
Results Overview
As evaluated by treating physician as possibly or probably related to intervention
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
528 participants
Primary outcome timeframe
Up to 33 days
Results posted on
2022-09-22
Participant Flow
Participant milestones
| Measure |
CeraVe Group
Participants in this group will receive the CeraVe Hydrating Cleanser and Moisturizing Cream for 28 days.
CeraVe Hydrating Cleanser: topical cleanser applied twice a day for 28 days
CeraVe Moisturizing Cream: topical cream applied twice a day for 28 days
|
|---|---|
|
Overall Study
STARTED
|
528
|
|
Overall Study
COMPLETED
|
528
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
CeraVe Group
n=528 Participants
Participants in this group will receive the CeraVe Hydrating Cleanser and Moisturizing Cream for 28 days.
CeraVe Hydrating Cleanser: topical cleanser applied twice a day for 28 days
CeraVe Moisturizing Cream: topical cream applied twice a day for 28 days
|
|---|---|
|
Age, Continuous
|
57.8 years
STANDARD_DEVIATION 12.3 • n=528 Participants
|
|
Sex: Female, Male
Female
|
327 Participants
n=528 Participants
|
|
Sex: Female, Male
Male
|
201 Participants
n=528 Participants
|
|
Diabetes mellitus type
Type 1
|
92 Participants
n=528 Participants
|
|
Diabetes mellitus type
Type 2
|
436 Participants
n=528 Participants
|
PRIMARY outcome
Timeframe: Up to 33 daysAs evaluated by treating physician as possibly or probably related to intervention
Outcome measures
| Measure |
CeraVe Group
n=528 Participants
Participants in this group will receive the CeraVe Hydrating Cleanser and Moisturizing Cream for 28 days.
CeraVe Hydrating Cleanser: topical cleanser applied twice a day for 28 days
CeraVe Moisturizing Cream: topical cream applied twice a day for 28 days
|
|---|---|
|
Percentage of Participants Reporting Adverse Events (AE)
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Up to 33 daysAs evaluated by treating physician as possibly or probably related to intervention
Outcome measures
| Measure |
CeraVe Group
n=528 Participants
Participants in this group will receive the CeraVe Hydrating Cleanser and Moisturizing Cream for 28 days.
CeraVe Hydrating Cleanser: topical cleanser applied twice a day for 28 days
CeraVe Moisturizing Cream: topical cream applied twice a day for 28 days
|
|---|---|
|
Percentage of Participants Reporting Adverse Events (AE)
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: At 33 daysPhysician-assessed number of participants at each Global Aesthetic Improvement Scale (GAIS). GAIS has gradings of very much improved, much improved, improved, no change and worse. A grading of worse means the least aesthetic improvement.
Outcome measures
| Measure |
CeraVe Group
n=528 Participants
Participants in this group will receive the CeraVe Hydrating Cleanser and Moisturizing Cream for 28 days.
CeraVe Hydrating Cleanser: topical cleanser applied twice a day for 28 days
CeraVe Moisturizing Cream: topical cream applied twice a day for 28 days
|
|---|---|
|
Number of Participants at Each GAIS Grading Scale
Very much improved
|
223 Participants
|
|
Number of Participants at Each GAIS Grading Scale
Much improved
|
224 Participants
|
|
Number of Participants at Each GAIS Grading Scale
Improved
|
72 Participants
|
|
Number of Participants at Each GAIS Grading Scale
No change
|
9 Participants
|
|
Number of Participants at Each GAIS Grading Scale
Worse
|
0 Participants
|
PRIMARY outcome
Timeframe: At 33 daysPhysician-assessed number of participants at each Dry Skin Scale. Scales will be evaluated for each of the following conditions: roughness/scaling, itch, pain, erythema and fissures. Each condition will be scored from 0 (none), 1 (almost none), 2 (mild), 3 (moderate) to 4 (severe).
Outcome measures
| Measure |
CeraVe Group
n=528 Participants
Participants in this group will receive the CeraVe Hydrating Cleanser and Moisturizing Cream for 28 days.
CeraVe Hydrating Cleanser: topical cleanser applied twice a day for 28 days
CeraVe Moisturizing Cream: topical cream applied twice a day for 28 days
|
|---|---|
|
Number of Participants at Each Dry Skin Scale
Pain - Severe
|
2 Participants
|
|
Number of Participants at Each Dry Skin Scale
Erythema - Mild
|
19 Participants
|
|
Number of Participants at Each Dry Skin Scale
Erythema - Moderate
|
6 Participants
|
|
Number of Participants at Each Dry Skin Scale
Erythema - Severe
|
1 Participants
|
|
Number of Participants at Each Dry Skin Scale
Fissures - None
|
408 Participants
|
|
Number of Participants at Each Dry Skin Scale
Fissures - Almost None
|
104 Participants
|
|
Number of Participants at Each Dry Skin Scale
Fissures - Mild
|
14 Participants
|
|
Number of Participants at Each Dry Skin Scale
Fissures - Moderate
|
0 Participants
|
|
Number of Participants at Each Dry Skin Scale
Fissures - Severe
|
2 Participants
|
|
Number of Participants at Each Dry Skin Scale
Roughness/scaling - none
|
271 Participants
|
|
Number of Participants at Each Dry Skin Scale
Roughness/scaling - Almost None
|
219 Participants
|
|
Number of Participants at Each Dry Skin Scale
Roughness/scaling - Mild
|
28 Participants
|
|
Number of Participants at Each Dry Skin Scale
Roughness/scaling - Moderate
|
7 Participants
|
|
Number of Participants at Each Dry Skin Scale
Roughness/scaling - Severe
|
3 Participants
|
|
Number of Participants at Each Dry Skin Scale
Itchiness - None
|
386 Participants
|
|
Number of Participants at Each Dry Skin Scale
Itchiness - Almost None
|
116 Participants
|
|
Number of Participants at Each Dry Skin Scale
Itchiness - Mild
|
21 Participants
|
|
Number of Participants at Each Dry Skin Scale
Itchiness - Moderate
|
1 Participants
|
|
Number of Participants at Each Dry Skin Scale
Itchiness - Severe
|
4 Participants
|
|
Number of Participants at Each Dry Skin Scale
Pain - None
|
494 Participants
|
|
Number of Participants at Each Dry Skin Scale
Pain - Almost
|
27 Participants
|
|
Number of Participants at Each Dry Skin Scale
Pain - Mild
|
4 Participants
|
|
Number of Participants at Each Dry Skin Scale
Pain - Moderate
|
1 Participants
|
|
Number of Participants at Each Dry Skin Scale
Erythema - None
|
409 Participants
|
|
Number of Participants at Each Dry Skin Scale
Erythema - Almost None
|
93 Participants
|
Adverse Events
CeraVe Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place